Cleared Traditional

VICTORY? Lumbar Plate System

K232318 · Globus Medical, Inc. · Orthopedic
Oct 2023
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K232318 is an FDA 510(k) clearance for the VICTORY? Lumbar Plate System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on October 31, 2023, 89 days after receiving the submission on August 3, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K232318 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 2023
Decision Date October 31, 2023
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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